FDA Adverse Event
Malfunction
Summary report: N
INTREL 3
MDR report key: 1885242
·
Received October 25, 2010
Report
- Report Number
- 6000032-2010-08376
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S DEVICE "STOPPED WORKING" AFTER A CARDIOVASCULAR PROCEDURE. IT WAS STATED THE PT WAS RECEIVING NO STIMULATION. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0023522P| MODEL 7425, LOT# NAT100269H| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7496-51, LOT# YR0009577N| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTABLE NEURO STIMULATOR| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7498-51, LOT# NED002049N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# L52039| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0014976P| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: |